Clinical Study for TONOREF III Tested to ANSI Z80.10-2014
NCT07152808 · Status: COMPLETED · Type: INTERVENTIONAL · Enrollment: 52
Last updated 2026-04-24
Summary
The primary objective of this clinical study was to show that tonometry values for TONOREF III, as the representative device of the NIDEK tonometer series, were comparable to the predicate device.
The secondary objective was to demonstrate that the test device was as safe as the predicate device.
Conditions
- Intraocular Pressure
Interventions
- DEVICE
-
NIDEK TONOREF III
The auto ref/kerato/tono/pachymeter TONOREF III is a medical device which measures objective refractive errors, corneal curvature radius, intraocular pressure and corneal thickness of the patient's eye.
- DEVICE
-
Haag-Streit Goldmann Manual Tonometer
Haag-Streit Goldmann Manual Tonometer measures intraocular pressure to aid in the screening and diagnosis of glaucoma
Sponsors & Collaborators
-
Nidek Co. LTD.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 22 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-09-02
- Primary Completion
- 2023-06-19
- Completion
- 2023-06-19
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